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The purpose of this survey is to collect selected safety data.
Primary Objective:
To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.
This is a retrospective survey to collect selected safety data at 6 months following the 4th dose of Pentacel® in children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series | Positive response is a 'Yes' to any of the following questions:
Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism? | 6 months post 4th dose vaccination |
| Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | SAE: any untoward medical occurrence with the following outcomes:
| 6 Months post 4th dose vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver | British Columbia | V5Z 4R4 | Canada |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 3214 participants that met the inclusion and exclusion criteria were enrolled in this survey. One participant did not return a record release form and twenty-nine (29) others were also excluded from the Primary Analysis Population because their safety data could not be confirmed.
Telephone contact for this study was from 20 September 2003 to 30 April 2004.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Received 4th dose of the Pentacel® series before 2nd birthday |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Received 4th dose of the Pentacel® series before 2nd birthday |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series | Positive response is a 'Yes' to any of the following questions:
Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism? | Participants who completed the whole survey. Those who had confirmed data, or had data that did not require confirmation, or had unconfirmed data. | Posted | Number | Particpants | 6 months post 4th dose vaccination |
|
Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacelâ„¢ vaccine.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | Received 4th dose of the Pentacel® series before 2nd birthday |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA 6.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D014917 | Whooping Cough |
| D006192 | Haemophilus Infections |
| D013742 | Tetanus |
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Received 4th dose of the Pentacel® series before 2nd birthday |
|
|
| Primary | Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | SAE: any untoward medical occurrence with the following outcomes:
| Response to questionnaire that were confirmed by the primary care physician's office were analyzed, Primary Analysis Population. Unconfirmed safety data form 29 participants were excluded from the primary analysis. | Posted | Number | Participants | 6 Months post 4th dose vaccination |
|
|
|
| 93 |
| 3,213 |
| 0 |
| 3,123 |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Immune system disorders | Immune system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| Injury, poisoning and procedural complication | Injury, poisoning and procedural complications | MedDRA 6.0 | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6.0 | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA 6.0 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | MedDRA 6.0 | Systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D016871 | Pasteurellaceae Infections |
| D003015 | Clostridium Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| Title | Measurements |
|---|---|
|
| Red cell aplasia (Related) |
|
| Vomiting nos (Any) |
|
| Vomiting nos (Related) |
|
| Difficulty in walking (Any) |
|
| Difficulty in walking (Related) |
|
| Pyrexia (Any) |
|
| Pyrexia (Related) |
|
| Hypersensitivity nos (Any) |
|
| Hypersensitivity nos (Related) |
|
| Bronchiolitis (Any) |
|
| Bronchiolitis (Related) |
|
| Bronchitis viral (Any) |
|
| Bronchitis viral (Related) |
|
| Bronchopneumonia nos (Any) |
|
| Bronchopneumonia nos (Related) |
|
| Cellulitis (Any) |
|
| Cellulitis (Related) |
|
| Croup infectious (Any) |
|
| Croup infectious (Related) |
|
| Gastroenteritis nos (Any) |
|
| Gastroenteritis nos (Related) |
|
| Gastroenteritis rotavirus (Any) |
|
| Gastroenteritis rotavirus (Related) |
|
| Gastroenteritis viral nos (Any) |
|
| Gastroenteritis viral nos (Related) |
|
| Herpes zoster (Any) |
|
| Herpes zoster (Related) |
|
| Kawasaki's disease (Any) |
|
| Kawasaki's disease (Related) |
|
| Lobar pneumonia nos (Any) |
|
| Lobar pneumonia nos (Related) |
|
| Localised infection (Any) |
|
| Localised infection (Related) |
|
| Periorbital cellulitis (Any) |
|
| Periorbital cellulitis (Related) |
|
| Pharyngitis (Any) |
|
| Pharyngitis (Related) |
|
| Pneumonia nos (Any) |
|
| Pneumonia nos (Related) |
|
| Pneumonia viral nos (Any) |
|
| Pneumonia viral nos (Related) |
|
| Tonsillitis viral nos (Any) |
|
| Tonsillitis viral nos (Related) |
|
| Upper respiratory tract infection nos (Any) |
|
| Upper respiratory tract infection nos (Related) |
|
| Urinary tract infection nos (Any) |
|
| Urinary tract infection nos (Related) |
|
| Viral infection nos (Any) |
|
| Viral infection nos (Related) |
|
| Femur fracture (Any) |
|
| Femur fracture (Related) |
|
| Hip dislocation (Any) |
|
| Hip dislocation (Related) |
|
| Diabetes mellitus nos (Any) |
|
| Diabetes mellitus nos (Related) |
|
| Acute lymphocytic leukaemia (Any) |
|
| Acute lymphocytic leukaemia (Related) |
|
| Autism (Any) |
|
| Autism (Related) |
|
| Convulsions nos (Any) |
|
| Convulsions nos (Related) |
|
| Febrile convulsion (Any) |
|
| Febrile convulsion (Related) |
|
| Breath holding (Any) |
|
| Breath holding (Related) |
|
| Balanitis nos (Any) |
|
| Balanitis nos (Related) |
|
| Asthma nos (Any) |
|
| Asthma nos (Related) |
|
| Bronchitis nos (Any) |
|
| Bronchitis nos (Related) |
|
| Pneumonia aspiration (Any) |
|
| Pneumonia aspiration (Related) |
|
| Wheezing (Any) |
|
| Wheezing (Related) |
|